Surgical device

ABSTRACT

A surgical device comprises a guide tube having a proximal end, a distal end, and an inside diameter. A needle has a proximal end and a distal end. The needle comprises a longitudinal portion having a diameter suitable to be slidably received within the inside diameter of the guide tube. The needle comprises a helical element disposed at the distal end of the needle.

BACKGROUND

Endoscopy refers to looking inside a human body for medical reasonsusing an instrument called an endoscope. Endoscopy is a minimallyinvasive diagnostic medical procedure used to evaluate interior surfacesof an organ or other tissue by inserting a small tube into the body,often, but not necessarily, through a natural body opening of a patientor through a relatively small incision. Using the endoscope, a surgeonmay view surface conditions of the organs or other tissue, includingabnormal or diseased tissue such as lesions and other various surfaceconditions. The endoscope may have a rigid or a flexible tube and, inaddition to providing an image for visual inspection and photography,the endoscope may be adapted and configured for taking biopsies,retrieving foreign objects, and introducing medical instruments to atissue treatment region, referred to generally herein as a surgicalsite.

Laparoscopic surgery is a minimally invasive surgical technique in whichoperations are performed through small incisions (usually 0.5 cm to 1.5cm) or keyholes, as compared to the larger incisions required intraditional open-type surgical procedures. Laparoscopic surgery includesoperations within the abdominal or pelvic cavities, whereas keyholesurgery performed on the thoracic or chest cavity is calledthoracoscopic surgery. Laparoscopic and thoracoscopic surgery belong tothe broader field of endoscopy.

A key element in laparoscopic surgery is the use of a laparoscope: atelescopic rod lens system that is usually connected to a video camera(single-chip or three-chip). Also attached is a fiber-optic cable systemconnected to a “cold” light source (halogen or xenon) to illuminate theoperative field and configured to be inserted through a 5 mm or 10 mmcannula to view the surgical site. The abdomen is usually insufflatedwith carbon dioxide gas to create a working and viewing space for asurgeon. Stated another way, the abdomen is essentially blown up like aballoon (i.e., insufflated) thereby elevating the abdominal wall abovethe internal organs like a dome. Carbon dioxide gas can be used for theinsufflation because it is common to the patient's body and can beremoved by the respiratory system if it is absorbed through tissue.

Minimally invasive therapeutic procedures used to treat diseased tissueby introducing medical instruments to the surgical site through anatural opening of a patient are known as Natural Orifice TranslumenalEndoscopic Surgery (NOTES™). In general, there are a variety of systemsfor inserting an endoscope through a natural opening in the human body,dissecting a lumen, and then, treating the inside of the abdominalcavity. For example, in U.S. Pat. No. 5,297,536 to Wilk, issued on Mar.29, 1994, which is hereby incorporated by reference in its entirety, asample treatment system is disclosed. This system is comprised of adissecting device for perforating a lumen wall, an endoscope insertmember for inserting an endoscope, a tube, an endoscope, and apneumoperitoneum device for deflating the abdominal cavity, and aclosing device.

When transluminal endoscopic surgery is carried out using theabove-referenced system, an overtube can first be inserted through anatural opening in the patient's body (e.g., mouth, anus, or vagina). Adistal end of the overtube may be attached to an organ wall or othertissue by vacuum pressure, thus being temporarily fixed thereon suchthat the organ wall or other tissue can be punctured. An incisinginstrument, such as a needle, for example, may be passed through theovertube from a proximal end of the overtube to a distal end of theovertube, and/or through a working channel of the endoscope, and used topuncture and create an opening through the organ wall or other tissue.An inflatable member, such as a medical balloon, for example, may bepositioned in the opening and then inflated to enlarge the opening. Oncethe opening has been enlarged by the inflatable member, the inflatablemember can be at least partially deflated and removed from the body andthe overtube may then be inserted into and partially through the openingto serve as a working channel for the endoscope and/or other surgicalinstruments or devices to the surgical site. After surgery of the insideof the organ or other tissue is complete, the overtube may be removedfrom the enlarged opening so that the opening can be closed by an O-ringor other suitable closure device and then the endoscope and the overtubemay be withdrawn from the body.

The peritoneum may be accessed through the stomach wall or wall of otherhollow body organs or internal body lumens, to achieve surgical therapyor diagnostic procedures therein. To minimize the potential forinadvertent damage to underlying organs or tissues, the piercing processrequired in the translumenal access of the peritoneum needs to be safeand controllable at the distal tip of an endoscope. Accordingly, in thefield of endoscopy, there remains a need for improved methods anddevices for translumenal access of internal body cavities using a needleand an inflatable member, to pierce the internal body lumens during anendoscopic surgical procedure.

FIGURES

The novel features of the various embodiments are set forth withparticularity in the appended claims. The various embodiments, however,both as to organization and methods of operation may best be understoodby reference to the following description, taken in conjunction with theaccompanying figures as follows.

FIG. 1 illustrates a perspective view of one embodiment of a surgicaldevice comprising a needle, an elongated guide wire, a conduit, aninflation conduit, an inflatable member, and a protective sleeve, whichis shown in an extended or a first position.

FIG. 2 illustrates a perspective view of one embodiment of the surgicaldevice of FIG. 1 with the protective sleeve shown partially retracted toexpose the needle and a tapered segment.

FIG. 3 illustrates a perspective view of one embodiment of the surgicaldevice of FIG. 1 with the protective sleeve shown retracted to a secondposition to expose the needle, the tapered segment, and the inflatablemember.

FIG. 4 illustrates an exploded view of one embodiment of an inflatablemember of the surgical device of FIG. 1.

FIG. 5 illustrates a cross-sectional view of one embodiment of thesurgical device taken along line 5-5 of FIG. 1.

FIG. 6 is a perspective view of a distal portion of one embodiment of aneedle of the surgical device of FIG. 1 showing a partialcross-sectional view of a guide tube to receive the needle.

FIG. 7 illustrates a perspective view of one embodiment of a protectivesleeve for the surgical device of FIG. 1.

FIG. 8 illustrates a perspective view of one embodiment of the surgicaldevice of FIG. 1 showing a protective sleeve in a retracted or secondposition exposing the needle, the tapered segment, and the inflatablemember in an inflated state.

FIG. 9 illustrates a perspective close-up view of one embodiment of thesurgical device of FIG. 1 showing a close-up view of a distal end of thesurgical device showing the protective sleeve in a retracted or secondposition exposing the needle, the tapered segment, and the inflatablemember with the inflatable member in an inflated state.

FIG. 10 illustrates a perspective close-up view of one embodiment of thesurgical device of FIG. 1 in fluid communication with a fluid sourceshowing the protective sleeve in a retracted or second position exposingthe needle, the tapered segment, and the inflatable member with theinflatable member in an inflated state.

FIG. 11 is a cross-sectional view of one embodiment of the surgicaldevice of FIG. 1.

FIG. 12 illustrates a cross-sectional view of a distal portion of oneembodiment of the surgical device of FIG. 1 extending through a workingchannel of an endoscope and creating an opening in tissue to allowaccess to a surgical site.

FIG. 13 illustrates a cross-sectional view of the distal portion of oneembodiment of the surgical device of FIG. 1 with the protective sleevein a first position and being advanced through the opening in thetissue.

FIG. 14 illustrates a cross-sectional view of the distal portion of oneembodiment of the surgical device of FIG. 1 after the protective sleevehas been retracted into the second position to expose the inflatablemember to the opening in the tissue.

FIG. 15 illustrates a cross-sectional view of the distal portion of thesurgical device of FIG. 1 after the protective sleeve has been retractedinto the second position and with the inflatable member sufficientlyinflated to expand the opening in accordance with one non-limitingembodiment

FIG. 16 illustrates a cross-sectional view of the distal portion of oneembodiment of the surgical device of FIG. 1 after the protective sleevehas been retracted into the second position and with the inflatablemember inflated to expand the opening in the tissue.

FIG. 17 illustrates one embodiment of the surgical device of FIG. 1being used in conjunction with an overtube, an endoscope, and variousother components and inserted into the upper gastrointestinal tract of apatient.

FIG. 18 illustrates a perspective view of the distal portion of oneembodiment of the surgical device of FIG. 1 extending from a workingchannel of a distal end of the endoscope of FIG. 17.

DESCRIPTION

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician, a surgeon, or a user (“surgeon”)manipulating one end of an instrument or device that protrudes out of apatient (i.e., a natural orifice). The term “proximal” refers to aportion of the instrument or device closest to the surgeon and the term“distal” refers to a portion of the instrument located furthest from thesurgeon. It will be further appreciated that for conciseness andclarity, spatial terms such as “vertical,” “horizontal,” “up,” and“down” may be used herein with respect to the figures. Surgicalinstruments or devices, however, may be used in many orientations andpositions and, as such, these terms are not intended to be limiting andabsolute.

During the course of various surgical procedures, such as inintralumenal and translumenal access procedures, for example, thereoften exists a need to pierce the wall of hollow body organs or internalbody lumens (“lumen” or “access lumen” hereinafter) with a needle toaccess a cavity, organ, or other lumen. From inside the lumen, a targetexit is selected and after suctioning the target exit site of the lumenonto the distal end of an endoscope, using a distal tip of anover-the-scope overtube/endotrocar conduit, or an end cap, an elongatedguide wire with a needle formed integrally at the distal end may beintroduced through a conduit, such as a catheter, to the target exitsite. The wall of the lumen may be pierced with a needle, a needleknife, or other cutting, piercing, incising, or puncturing member(“needle”) in accordance with the described embodiments. In variousembodiments, the needle may be solid or hollow such that the most distalend of the needle can puncture tissue. In one embodiment, the needlecomprises an elongated member referred herein as a guide wire, a spiral,helical, or corkscrew shaped portion with a sharp metallic point or tipfor piercing at a distal end (“helical portion” hereinafter), and in oneembodiment, a tapered segment at the proximal end of the helicalportion. Due to the nature of the helical portion, in one embodiment,the wall of the lumen may be pierced using a twisting motion (e.g.,clockwise or counterclockwise) of the helical portion, of the needle,for example, which may be imparted by twisting the distal end of theguide wire, which extends outside the patient's body. The needle,including the guide wire, tapered segment, and helical portion, may beconstructed of any suitable metals or alloys such as stainless steel,alloys of stainless steel, shape memory alloys such as nickel titanium(NiTi) commercially known as NITINOL, or any other materials suitablefor piercing the walls of hollow organs or lumens.

As previously discussed, in one embodiment, a portion or segment of theelongated guide wire portion of the needle proximal to the helicalportion may be tapered (necked down) to a smaller diameter to reduce thecolumn strength of the guide wire, limiting the likelihood of damage tounintended anatomical structures once the guide wire is advanced througha catheter (e.g., a flexible or rigid hollow tube or conduit). This mayallow a length of the guide wire to be fed into the peritoneum, or otherhollow body cavity or lumen, outside the access lumen and left in placeas a future path for repeated ingress/egress with an endoscope. In otherembodiments, the helical portion may be formed separately from the guidewire portion and attached thereto using any known attachment technique.Once the helical portion and the guide wire are attached or formedintegrally on a distal end thereof, the entire assembly may be referredto as a “needle” and/or guide wire, for example.

Once the wall of the access lumen is pierced with the helical needle, aninflatable member, such as a medical balloon, for example, may be usedto enlarge the opening or incision in the wall or other tissue(“opening”) formed with the helical portion of the needle. The openingis enlarged to create surgical space for advancing overtubes andsurgical instruments or devices and/or for allowing a surgeon to accessthe translumenal surgical site. These inflatable members arecommercially available from Boston Scientific Corporation, C. R. Bard,Inc., and Cook Medical Inc., for example. The inflatable member is thenpushed behind the helical needle and dilated to stretch the exit site inpreparation for an over-the-scope overtube/endotrocar entry, providingan atraumatic ingress/egress path for the endoscope.

In various embodiments, an overtube comprising a hollow conduit,different from a guide tube or guide wire conduit, can be introducedinto a natural opening in a patient's body. In one embodiment, a guidetube or guide wire conduit can be inserted into the overtube which hasbeen inserted into the natural opening in the patient's body. In oneembodiment, an endoscope can be inserted into the overtube through theproximal end of the overtube and extend through or near the distal endof the overtube. In such an embodiment, the conduit can be positionedwithin a working channel of the endoscope and can extend from a distalend thereof to allow the conduit and the needle to gain access to thetissue proximal to a surgical site or surgical access site.

In various embodiments, an inflatable member, such as a medical balloon,for example, can be attached to, positioned on, surround, or can beintegrally formed on or with an outer surface of a distal portion of theguide wire conduit, for example, and can be introduced into the openingin the tissue created by advancing the needle distally through thetissue. The inflatable member can then be transitioned from anuninflated or a collapsed state to an inflated or an expanded statethereby radially or otherwise displacing side walls of the opening tocreate a larger opening or surgical space in the tissue such that theenlarged opening can receive a portion of the endoscope, a portion ofthe overtube, and/or portions of other surgical instruments or devices,for example, therethrough.

In various embodiments, an inflation conduit can surround a portion of aconduit and can extend from a fluid source to a proximal portion of theinflatable member such that the inflatable member can be expanded withfluid from the fluid source. In one embodiment, the inflation conduitcan comprise an inner diameter or perimeter larger than the outerdiameter or perimeter of the conduit to allow the fluid from the fluidsource to flow or be pumped into and out of the inflatable member. Thefluid from the fluid source can flow or be pumped through a void createdbetween the outer diameter or perimeter of the conduit and the innerdiameter or perimeter of the inflation conduit, for example. As such, adistal portion of the inflation conduit can be attached to and in fluidcommunication with the proximal portion of the inflatable member with adistal portion of the inflatable member sealed to a portion of theconduit or member positioned on the conduit such that the inflatablemember can be inflated. In other various embodiments, the inflationconduit can be eliminated and end portions of the inflatable member canbe sealed to the conduit. The conduit can be in fluid communication withthe fluid source at its proximal portion and be in fluid communicationwith the inflatable member at its distal portion through an opening,aperture, slot, or perforation (not illustrated) in the conduit. As aresult, the fluid from the fluid source can be flowed or pumped into theconduit and through the opening, aperture, slot, or perforation, whichcan be in fluid communication with an internal area of the inflatablemember to inflate the inflatable member.

Because the inflatable member is made of a very thin material, such aspolyethylene terephthalate glycol, polyurethane, plastic, nylon, orcombinations thereof, for example, it can be somewhat susceptible totearing or puncturing while it is being fed through the overtube, theworking channel of the endoscope, and while it is being advanced throughthe opening in the tissue. Further, the inflatable member can sometimesat least partially inflate prior to being positioned within the openingin the tissue owing to subatmospheric pressure conditions within theovertube. These subatmospheric pressure conditions can cause theinflatable member to prematurely inflate if the inflatable member is influid communication with atmospheric pressure or with a space having ahigher pressure than the subatmospheric pressure conditions within theovertube. Even if a valve is supplied between the inflatable member andan atmospheric pressure space external to the patient, any fluid withinthe conduit and/or the inflation conduit may cause the inflatable memberto at least partially inflate owing to the fluid remaining within theconduit and/or the inflation conduit intermediate the valve and theinflatable member. Such premature inflation can cause delays during asurgical procedure as a partially inflated inflatable member may not fitproperly into the opening in the tissue. To at least partially alleviateor eliminate the above-referenced difficulties, a surgical device isprovided with a protective sleeve which can, in some circumstances, atleast partially cover the inflatable member at appropriate times duringa surgical procedure to prevent, inhibit, or at least minimizeopportunities for tearing, puncturing, or premature inflation of theinflatable member. The protective sleeve also may be provided to protectthe endoscope channel from sharp points, and to keep the inflatablemember properly pleated during initial insertion as described inaccordance with the disclosed embodiments.

With reference now to FIGS. 1-5, illustrates a one embodiment of asurgical device 10 comprising a needle 5, an elongated guide tube 13, aconduit 11, an inflation conduit 12, and an inflatable member 16 coveredby a protective sleeve 18 in an extended or a first position. A distalend 9 of the surgical device 10 comprises, the needle 5 comprises ahelical element 14, a tapered element 15 located proximally relative tothe helical element 14, and an elongated portion that is accessible at aproximal end 7 of the surgical device 10. In the embodiment, illustratedin FIGS. 3 and 5, the inflatable member 16 comprises a plurality oflongitudinal pleats 35. The inflatable member 16 is disposed on anoutside surface of the conduit 11, is in fluid communication with theinflation conduit 12, and is slidably received within the protectivesleeve 18, to keep the inflatable member 16 properly pleated duringinitial insertion. In one embodiment, the surgical device 10 can beinserted into and extend through a distal end of a working channel of anendoscope positioned within an overtube, as described in further detailbelow. In various embodiments, the surgical device 10, via its variouscomponents such as the helical element 14, can be used to puncturetissue to create an opening therein and then expand the opening usingthe inflatable member 16, such that an overtube, the endoscope, and/oranother surgical instrument or device can be advanced distally throughthe opening to gain access to a surgical site.

The protective sleeve 18 optionally comprises a handle or handle 20 onits proximal portion to slidably located the protective sleeve 18 in oneor more desired positions. The protective sleeve 18 is configured to bepositioned at least partially over (i.e., cover) the helical element 14and the inflatable member 16 to protect and shield the inflatable member16 from tearing, puncturing, and/or premature inflation, for example,and to prevent or minimize opportunities for the helical element 14 topuncture undesired tissue or damage any of the instruments duringdeployment. As previously discussed, the protective sleeve 18 keeps theinflatable member 16 properly pleated during initial insertion. Usingthe handle 20, a clinician can be push the protective sleeve 18 distallyin the direction indicated by arrow “A” to deploy the protective sleeve18 as shown in FIG. 1. The protective sleeve 18 can be pulled proximallyin the direction indicated by arrow “B” to expose the distal end 9 ofthe needle 5, the helical element 14 and the tapered element 15, asshown in FIG. 2, where the protective sleeve 18 is in a partiallyretracted first position exposing the helical element 14 and the taperedelement 15. The protective sleeve 18 can be pulled proximally further inthe direction indicated by arrow “B” to also expose inflatable member16, as shown in FIGS. 3 and 4, for example, where the protective sleeve18 is shown in a further retracted second position exposing the helicalelement 14, the tapered element 15, and the inflatable member 16.

In various embodiments, the needle 5 may be formed in a variety ofconfigurations. In one embodiment, the helical element 14, the taperedelement 15, and the elongated portion of the needle may be formedintegrally or as separate attachable elements. For example, the helicalelement 14 may be attachable to the tapered element 15, which may beattachable to the elongated portion of the needle 5. These elements maybe attached using any suitable techniques, such as, for example,bolting, screwing, welding, crimping, gluing, epoxying, bonding,brazing, soldering, press fitting, snap fitting, riveting, heatshrinking, ultrasonic welding or any other suitable method. In otherembodiments, the helical element 14 and/or the tapered element 15 may beattached to the distal end of the guide tube 13, thus eliminating theneed for the elongated portion of the needle 5. In this respect, theterms guide tube 13 and needle 5 may be used interchangeably and theguide tube 13 may take the form of a solid or stranded wire and hencemay be referred to as a guide wire, without limitation. In otherembodiments, the helical element 14 and/or the tapered element 15 may beformed integrally on a distal end of the guide tube 13. Therefore, theterm “needle” may encompass the guide tube 13 with an attached helicalelement 14 and/or tapered element 15 or the guide tube 13 with anintegrally formed helical element 14 and/or tapered element 15, withoutlimitation.

The helical element 14 portion of the needle 5 may be employed topenetrate, pierce, cut, incise, grasp, or puncture tissue in accordancewith the described embodiments. In one embodiment, the helical element14 comprises a spiral, helical, or corkscrew (“helical” hereinafter)shape with a sharp metallic point or tip at the distal end that issuitable for penetrating tissue. The helical element 14 can be formedwith a wire or tube having an outside diameter suitable for penetrating,piercing, cutting, incising, grasping, or puncturing tissue.Accordingly, the wall of an internal body lumen may be pierced using atwisting motion of the helical element 14, for example. In theillustrated embodiment, an internal body lumen may be pierced bythreading or twisting the helical element 14 in a clockwise direction asillustrated by arrow “CW,” in FIGS. 2-4, for example. In otherembodiments, however, to pierce the lumen the helical element 14 may bethreaded or twisted in a counterclockwise direction. Once an initialopening is formed in the lumen using the helical element 14, the taperedelement 15 portion and the guide tube 13 may be fed into the peritoneum,or other hollow body cavity or lumen, outside the access lumen, and leftin place as a future path for repeated ingress/egress with an endoscope.The helical element 14 may be constructed of any suitable metals oralloys such as stainless steel, alloys of stainless steel, shape memoryalloys such as nickel titanium (NiTi) commercially known as NITINOL, orany other materials suitable for piercing the walls of hollow organs orlumens. When formed of a shape memory alloy, the helical element 14 maybe pulled in direction “B” through the opening defined by the guide tube13.

For additional clarity, FIG. 5 illustrates a cross-sectional view of theembodiment of the surgical device 10 taken along line 5-5 of FIG. 1 toillustrate the relative positions of the protective sleeve 18, theinflation conduit 12, the conduit 11, the guide tube 13, and the needle5 and one embodiment of how these elements can be situated. Theprotective sleeve 18 can have an inner diameter or perimeter which islarger than a respective outer diameter or perimeter of the inflatableinflation conduit 12, the conduit 11, and the inflatable member 16 toenable the protective sleeve 18 to at least partially or fully surrounda portion of the inflatable inflation conduit 12 and/or the inflatablemember 16.

An enlarged view of the tapered element 15 is shown in FIG. 6. In oneembodiment, a distal portion of the needle 5 proximal the helicalelement 14 may be tapered (necked down) to a smaller diameter to definethe tapered element 15. The tapered element 15 comprises a middlesegment 23 having a diameter d₁ that is less than the outside diameterd₁ of the elongated portion of the needle 5. A first tapered segment 25reduces the outside diameter OD₅ of the needle 5 to the diameter d₂ ofthe middle segment 23 and a second tapered segment 27 reduces thediameter d₃ of the helical element 14 to the diameter d₂ of the middlesegment 23. In one embodiment the diameter d₁ of the needle 5 issubstantially the same as the diameter d₃ of the helical element 14,however, in other embodiments the diameters d₁ and d₃ may be different.The middle segment 23 portion of the tapered element 15 makes middlesegment 23 slightly bendable or collapsible under an appliedlongitudinal force, which may result when pushing on the needle 5 indirection “A,” for example. Thus, the tapered element 15 reduces thecolumn strength of the needle 5 to minimize or limit the likelihood ofunintentionally damaging anatomical structures when the needle 5 isadvanced translumenally through layers of tissue. The bendability orcollapsibility of the tapered segment 23 prevents a build up of pressureagainst the tissue to be pierced and allows a more controlledadvancement of the distal portion of the needle 5 though the tissue.

FIG. 7 illustrates a perspective view of the embodiment of theprotective sleeve 18 of the surgical device of FIG. 1. As previouslydiscussed, the protective sleeve 18 can be movable by way of the handle20, for example, between the first position (see e.g., FIG. 1), tocover, or at least partially cover, the helical element 14, the taperedelement 15, and the inflatable member 16, and a second position (seee.g., FIG. 3), where it can expose the helical element 14, the taperedelement 15, and the inflatable member 16 for inflation. In oneembodiment, using the handle 20, a clinician (e.g., surgeon) can slidethe protective sleeve 18 between the first position and the secondposition (or into any other suitable intermediate position) by applyinga proximal-to-distal force, in direction A (i.e., pushing, as shown inFIGS. 1 and 3), or by applying a distal-to-proximal force, in directionB (i.e., pulling, as shown in FIGS. 2 and 3). The optional handle 20 maybe integrally formed with or on or attached to a proximal portion of theprotective sleeve 18 to facilitate slidable movement of the protectivesleeve 18 relative to the inflation conduit 12. It will be appreciatedby those of ordinary skill in the art that any suitable handle orgripping device can be used with the surgical device 10. Further, thehandle 20 can be eliminated and the surgeon can instead grasp theproximal portion of the protective sleeve 18 to move the protectivesleeve 18 between the first and the second positions and any othersuitable positions. In one embodiment, the protective sleeve 18 may befrictionally coupled or engaged to the inflation conduit 12 in anysuitable manner. It will be appreciated by those of ordinary skill inthe art that any other suitable mechanical members can be used toadvanced and/or retract the protective sleeve 18 relative to theinflation conduit 12. In other various embodiments, the advancement andretraction of the protective sleeve 18 can be automated through the useof at least one actuator, for example.

In one embodiment, the protective sleeve 18 and the handle 20 may beattached using any suitable techniques, such as, for example, bolting,screwing, welding, crimping, gluing, epoxying, bonding, brazing,soldering, press fitting, snap fitting, riveting, heat shrinking,ultrasonic welding or any other suitable method. In one embodiment, theprotective sleeve 18 and the handle 20 may be threadably connected, forexample. The handle 20 can have female threads formed on an innersurface thereof and the protective sleeve 18 can have male threadsformed on an outer surface thereof such that the threads on the outersurface of the protective sleeve 18 engage the threads on the innersurface of the handle 20. In another embodiment, the protective sleeve18 and the inflation conduit 12 may be threadably connected, forexample. The inflation conduit 12 can have male threads formed on anouter surface thereof and the protective sleeve 18 can have femalethreads formed on an inner surface thereof such that the threads on theinner surface of the protective sleeve 18 engage the threads on theouter surface of the inflation conduit 12.

With reference now to FIGS. 1-7, generally, the inflation conduit 12 maydefine a longitudinal opening therethrough long enough to extend from aproximal end of the inflatable member 16 to a proximal end 7 of thesurgical device 10. The inflation conduit 12 may be formed of or maycomprise a flexible material to allow at least its distal portion totravel through the tortuous path within the patient's body to and atleast partially through the opening in the tissue. In one embodiment,the needle 5 can be sized and configured to be slidably disposed withinthe guide tube 13. The guide tube 13 and the needle 5 may sized andconfigured to be slidably disposed within the conduit 11, which extendsfrom a distal portion of the inflatable member 16 to a proximal end 7 ofthe surgical device 10.

In one embodiment, the various components of the surgical device 10 mayhave the following dimensions selected such that the various internalcomponents are slidably movable within certain defined openings of theexternal components. Accordingly, in one embodiment, the protectivesleeve 18 has an inside diameter ID₁ of about 2.4 mm and an outsidediameter OD₁ of about 2.6 mm. The outside diameter OD₁ of the protectivesleeve 18 is selected such that it is slidably movable within a typicalworking channel of an endoscope, which typically may vary from about 2.8mm to about 3.7 mm. The inflation conduit 12 has an inside diameter ID₂of about 1.8 mm and an outside diameter OD₂ of about 2.3 mm. The outsidediameter OD₂ of the inflation conduit 12 is less than the insidediameter ID₁ of the protective sleeve 18 such that the protective sleeve18 can slidably move over the inflation conduit 12. The conduit 11 hasan outside diameter OD₃ of about 1.5 mm and an inside diameter ID₃ ofabout 1.0 mm. The outside diameter OD₃ of the conduit 11 is less than aninside diameter ID₂ of the inflation conduit 12 such that the conduit 11can be slidably received within the longitudinal opening defined by theinflation conduit 12. The guide tube 13 has an outside diameter OD₄ ofabout 0.9 mm and an inside diameter ID₄ of about 0.7 mm, which is lessthan the inside diameter ID₃ of the conduit 11 such that the guide tube13 can slidably move within the conduit 11. The needle 5 has an outsidediameter OD₅ ranging from about 0.4 mm to about 0.5 mm, which is lessthan the inside diameter ID₄ of the guide tube 13 such that the needle 5is slidably movable within the longitudinal opening defined by the guidetube 13. In one embodiment, the inflation conduit 12 and the conduit 11are fixed and the needle 5 is configured to be slidably movable withinthe longitudinal opening defined by the guide tube 13. In anotherembodiment, the guide tube 13 may be slidably movable within thelongitudinal opening defined by the conduit 11 and/or the inflationconduit 12. These dimensions are provided merely as examples and are notlimited in this context.

In various embodiments, apertures, cut-outs, slots, and/or joints (notshown) may be formed on the protective sleeve 18 to make the devicelighter and/or for various surgical reasons, such as, for example, toadd flexibility to the protective sleeve 18 and/or to facilitate thesteerability of the protective sleeve 18. Also, the protective sleeve 18can be formed of or comprise a transparent or semi-transparent material.In one embodiment, the protective sleeve 18 may be formed of or maycomprise a lubricious, low coefficient of friction material, such aspolyethylene, polyetheretherketone (PEEK®), polytetrafluoroethylene(TEFLON®), plastic, nylon, ethylene, and/or a combination thereof, forexample, to enable easy sliding movement of the protective sleeve 18over the inflation conduit 12 and/or the inflatable member 16. In suchan embodiment, the lubricious, low coefficient material can also helpprevent, inhibit, or at least minimize any opportunities for theprotective sleeve 18 from tearing or puncturing the inflatable member 16when sliding over the inflatable member 16 and/or when sliding betweenthe first position and the second position. In various embodiments, theprotective sleeve 18 can be flexible as required for traveling along thetortuous path inside the patient's body to the surgical site. In othervarious embodiments, portions of the protective sleeve 18 can beflexible while other portions can be rigid or semi-rigid, for example.As previously discussed, the protective sleeve 18 may compriseadditional features to enhance its flexibility and/or steerability.

With reference now to FIGS. 8-11, the surgical device 10 is shown withthe protective sleeve 18 in a retracted or second position and theinflatable member 16 exposed and inflated through the use of a fluidsource 22 (e.g., liquid or gas). In the embodiment illustrated in FIGS.8-11, the inflatable member 16 is in fluid communication with the fluidsource 22, which is configured to supply a fluid for filling orinflating the inflatable member 16 at an appropriate time during thesurgical procedure. The fluid source 22 can be in fluid communicationwith the inflatable member 16 through the inflation conduit 12. In oneembodiment, fluid source 22 can be in fluid communication with theinflatable member 16 through a tube 21 connecting the fluid source 22and the inflatable member 16 through the inflation conduit 12. The fluidsource 22 can be in fluid communication with the inflatable member 16through the inflation conduit 12 and an optional tube 21 connecting thefluid source 22 and the inflation conduit 12. A proximal handle 29 (FIG.11) may be provided to apply a torque to the guide tube 13.

As previously discussed, the inflation conduit 12 can extend at leastfrom the proximal portion of the inflatable member 16 to the tube 21 (orthe inflatable member 12 can extend directly to the fluid source 22) andcan have an inner diameter or perimeter larger than the outer diameteror perimeter of the conduit 11. As such, a void can be formedintermediate the inner surface of the inflation conduit 12 and the outersurface of the conduit 11. The inflatable member 16 can also be sealedwith the conduit 11 or other member on the conduit 11 at its distalportion and can be in fluid communication with the inflation conduit 12on its proximal portion such that the inflatable member 16 can beinflated by the fluid source 22. The fluid from the fluid source 22 canthen be flowed or pumped through the tube 21, through the void, and theninto the inflatable member 16. In one embodiment, the inflatable member16 may be inflated by controlling a control unit (not illustrated)external to the patient that can be operated by the surgeon. In otherembodiments, the inflatable member 16 may be inflated by the surgeonactivating a manual pump or another suitable inflation device, forexample.

In various embodiments, the inflatable member 16 can be filled with afluid, in liquid or gas form, such as saline or carbon dioxide, forexample, as such fluids are common to the patient's body and can beeasily absorbed and/or exhausted by the body. In various embodiments, asthe inflatable member 16 is filled with the fluid, the inflatable member16 can expand radially outward from the inflation conduit 12 to enlargethe size of the opening in the tissue. It will be appreciated that theinflatable member 16 can expand in any suitable fashion depending on theconfiguration of the inflatable member 16 and the particular surgicalneed.

As shown in more detail in FIG. 9, the conduit 11 may be disposed withinthe inflation conduit 12. The conduit 11 provides a channel for theguide tube 13. The conduit 11 is attached to the distal end of theinflatable member 16 and extends therefrom to the proximal end 7 of thesurgical device 10. The inflation conduit 12 is attached to the proximalend of the inflatable member 16 and extends therefrom to the proximalend 7 of the surgical device 10. The proximal end of the inflatablemember 16 is in fluid communication with the inflation conduit 12 andthe inflation source 22. The distal end of the inflatable member 16 issealed between the outside diameter surface of the conduit 11 and theinside diameter surface of a tapered tip 17.

In various embodiments, the proximal end of the inflatable member 16 canbe integrally formed with, integrally formed on, positioned on, orattached to an outer surface of the distal portion of the inflationconduit 12. In various embodiments, the proximal end of the inflatablemember 16 partially surrounds the distal portion of the inflationconduit 12. As the inflatable member 16 can surround the distal portionof the inflation conduit 12, it may have a larger, or slightly larger,outer perimeter or diameter than the outer perimeter or diameter of theinflation conduit 12 in its uninflated state. Likewise, as the inflationconduit 12 can surround a portion of the conduit 11, it can have alarger, or slightly larger, outer perimeter or diameter than the outerperimeter or diameter of the conduit 11. It will be appreciated thatmore than one inflatable member can be used with the surgical device 10as is recognized by those of ordinary skill in the art. Further, theinflatable member 16 may comprise any suitable inflatable member knownto those of ordinary skill in the art.

FIGS. 12-16 illustrate the surgical device 10 at various stages ofdeployment through a cross-section of tissue 32. In use, the surgicaldevice 10 can be configured to be slidably received within an overtube24 and an endoscope 26 comprising at least one working channel 28. Theendoscope 26 can be any suitable endoscope known to those of ordinaryskill in the art. In various embodiments, the overtube 24 can first beinserted into a natural orifice of a patient's body. In at least oneembodiment, the endoscope 26 can then be positioned within and extend atleast partially through the overtube 24 or extend to or from a distalend 30 of the overtube 24. In at least one embodiment, the distal end 30of the overtube 24 can engage the tissue 32 and can apply suction to thetissue 32 owing to the subatmospheric pressure conditions created withinthe overtube 24. The overtube 24 can be in fluid communication with anysuitable suction source such as a vacuum pump, for example, (notillustrated) or other suitable vacuum producing device. Appropriate endseals (not illustrated) may be provided to maintain the subatmosphericpressure conditions within the overtube 24. These subatmosphericpressure conditions within the overtube 24 can cause a portion of thetissue 32 proximal to a surgical access site to be pulled or drawn intothe overtube 24 to locate the tissue 32 for puncturing with the helicalelement 14 of the guide tube 13 of the surgical device 10. The suctionapplied to the tissue 32 at the distal end 30 of the overtube 24 can atleast partially offset any proximal-to-distal (i.e., pushing) force, indirection “A” (as shown in FIGS. 1 and 3), being applied to the tissue32. The helical element 14 of the needle 5 is advanced until it contactsthe tissue 32. As previously discussed, the tissue 32 may be pierced bythreading the helical element 14 in a clockwise rotation “CW.”

As previously referenced, if the proximal end of the inflation conduit12 and/or the conduit 11 is open to atmospheric pressure (i.e., notsealed), or even if the inflation conduit 12 and/or the conduit 11 has avalve at its proximal end, the inflatable member 16 could still, atleast partially, prematurely inflate owing to the subatmosphericpressure conditions within the overtube 24. As previously discussed,premature inflation of the inflatable member 16 can cause the inflatablemember 16 to be enlarged such that it may not fit within the opening inthe tissue 32. To address this issue, the protective sleeve 18 may belocated in the first position to prevent, inhibit, or at least minimizesuch premature inflation from occurring by containing the inflatablemember 16 within the inflation conduit 12 and thus inhibiting, forexample, the inflatable member from expanding outwardly relative to theinflation conduit 12 and/or the conduit 11 prior to an appropriate timeduring a surgical procedure. Stated another way, the protective sleeve18 can surround the inflatable member 16 closely enough to at leastinhibit the inflatable member 16 from prematurely inflating.Furthermore, to any extent that the inflatable member 16 may partiallyinflate due to the tolerances of manufacturing, the inflatable member 16can be contained within the hollow elongate opening defined by theprotective sleeve 18 and, thus, can be inhibited from inflation by theprotective sleeve 18, for example.

With reference to FIGS. 12 and 13, while the suction is applied to thetissue 32, the helical element 14 is advanced into the tissue 32 bythreading the helical element 14 in a clockwise rotation “CW” topuncture or pierce the tissue 32 and create an initial “helical needlesized” opening 34 therein. Once the helical element 14 has punctured orpierced through the tissue 32 and has created the opening 34, the distalend 9 of the surgical instrument is advanced through the opening 34. Thetapered tip 17 at the distal end of the inflatable member 16 is thenadvanced through the opening 34, stretching it to advance the inflatablemember 16 to a position within the opening 34. Owing to the position ofthe inflatable member 16 on or attachment to, for example, the distalportion of the inflation conduit 12 and the relative stretchability ofthe tissue 32, the inflatable member 16 can be advanced distally toward,into, and at least partially through the opening 34 in the tissue 32.This advancement can be accomplished by the surgeon applying aproximal-to-distal (i.e., pushing) force to the proximal portion of theinflation conduit 12 in direction “A.” While advancing the inflationconduit 12, the protective sleeve 18 can also be advanced by the surgeonagain applying a proximal-to-distal (i.e., pushing) force to theproximal portion of the protective sleeve 18 and/or to the handle 20, indirection “A,” to maintain the inflatable member 16 in a shielded orprotected state (i.e., the first position) until it is ready to beinflated.

FIG. 13 illustrates one stage of deployment of the surgical device 10through the cross-section of tissue 32. As illustrated, the protectivesleeve 18, along with the inflation conduit 12 and the inflatable member16, can be advanced at least partially through the opening 34 in thetissue 32 with the protective sleeve 18 in the first position to coverthe inflatable member 16. In this manner, the protective sleeve 18shields the inflatable member 16 and protects it from puncturing ortearing during the advancement stage of deployment. The protectivesleeve 18 generally should be advanced through the opening 34 in thetissue 32 while in the first position, although the inflation conduit 12and the inflatable member 16 could be advanced through the opening 34when the protective sleeve 18 is in the second position or in any othersuitable intermediate position.

Referring to FIG. 14, once the protective sleeve 18, the inflationconduit 12, and the inflatable member 16 are advanced through theopening 34 in the tissue 32, the protective sleeve 18 can be retractedinto the second position. This retraction can be accomplished by thesurgeon applying a distal-to-proximal (i.e., pulling or retracting)force, in the direction “B,” to the proximal portion of the protectivesleeve 18 and/or to the optional handle 20. As illustrated in FIG. 14,when the protective sleeve 18 is retracted into the second position, theinflatable member 16 can be exposed such that it can be inflated via theinflation conduit 12 and the fluid source 22 to expand the opening 34 inthe tissue 32.

As shown in FIG. 15, before the inflatable member 16 is inflated, thedistal end 30 of the overtube 24 can be partially withdrawn from contactwith the tissue 32 to alleviate or eliminate the suction being appliedto the tissue 32. Alternatively, the vacuum source could be powered off,for example, while maintaining the distal end 30 of the overtube 24 incontact with the tissue 32. The fluid source 22 (see FIG. 7) can thenflow a fluid into the inflatable member 16 through the inflation conduit12 to inflate the inflatable member 16. Alternatively, the conduit 11may be configured such that the fluid can be flowed through the conduit11 to inflate the inflatable member 16.

As shown in FIG. 15, as the inflatable member 16 is filled with thefluid, the inflatable member 16 can apply a force to the sidewalls 36 ofthe opening 34 created in the tissue 32 to radially or otherwise expandthe opening 34 given the relatively elastic properties of the tissue 32.This expansion can continue until the opening 34 is large enough toaccommodate the distal end 30 of the overtube 24 and/or the distal endof the endoscope 26 therethrough, for example. Once the opening 34 isexpanded to a suitable size by the inflatable member 16, the fluid canbe withdrawn, pumped, or otherwise removed from the inflatable member 16and flowed back into the fluid source 22 through the inflation conduit12 or the conduit 11, for example. After a sufficient amount of thefluid, or substantially all of the fluid, is withdrawn from theinflatable member 16, the surgical device 10, comprising the inflationconduit 12, the helical element 14, the tapered element 15, theinflatable member 16, the conduit 11, and the protective sleeve 18, canbe withdrawn from the working channel 28 of the endoscope 26. Withdrawalof the surgical device 10 from the working channel 28 allows othersurgical instruments or devices to be inserted into the working channel28 and extended from the distal end of the working channel 28 to obtainaccess to the surgical site through the opening 34 in the tissue 32. Itwill be appreciated that endoscopes may comprise more than one workingchannel. Accordingly, other surgical instruments may be inserted throughany of these additional working channels enabling the surgical device 10to remain in-situ, for example, during a surgical procedure.

As illustrated in FIG. 16, this expansion can continue until the opening34 is large enough to accommodate the distal end 30 of the overtube 24and/or the distal end of the endoscope 26 therethrough, for example.Once the inflatable member 16 is inflated it fills the inside diameterof the distal end of the overtube 24, making it substantially contiguouswith the overtube 24. The inflated inflatable member 16 acts as a tipfor leading in and pushing the entire overtube 24 and endoscope 26assembly through the opening 34 formed in the tissue 32 (e.g., stomachor other hollow organ wall). Once the opening 34 is expanded to asuitable size by the inflatable member 16, the fluid can be withdrawn,pumped, or otherwise removed from the inflatable member 16 and flowedback into the fluid supply 22 through inflation conduit 15 or theconduit 12. After a sufficient amount of the fluid, or substantially allof the fluid, is withdrawn from the inflatable member 16, the surgicalaccess device 10, comprising the conduit 12, the needle 14, theinflatable member 16, the inflation conduit 15, and the protectivesleeve 18, can be withdrawn from the working channel 28 of the endoscope26. Withdrawal of the surgical access device 10 from the working channel28 allows other surgical instruments or devices to be inserted into theworking channel 28 and extended from the distal end of the workingchannel 28 to obtain access to the surgical site through the opening 34in the tissue 32. It will be appreciated that endoscopes may comprisemore than one working channel. Accordingly, other surgical instrumentsmay be inserted through any of these additional working channelsenabling the surgical access device 10 to remain in-situ, for example,during a surgical procedure. It will be appreciated that the overtube 24can remain inserted through the opening 34 and the endoscope 26withdrawn such that other instruments can be advanced through theovertube 24 to the surgical site.

In various embodiments, the overtube 24 can generally be flexible so asto allow navigation through the tortuous pathway of a body lumen duringan endoscopic procedure. The size of the overtube 24 can vary but, invarious embodiments, it can have a length that allows it to be insertedtranslumenally through a patient's esophagus and an inner diameter orperimeter suitable to receive the endoscope 26 therein. The overtube 24can be made flexible using various techniques. For example, the overtube24 can be formed from a flexible material and/or it can include one ormore features formed therein to facilitate flexibility, such as aplurality of cut-outs or slots, for example. In other embodiments, theovertube 24 can be formed from a plurality of linkages that are movablycoupled to one another. The overtube 24 can also include regions thatvary in flexibility. For example, certain portions of the overtube 24,such as the distal portion, can be more rigid than other portions of theovertube 24, such as the proximal portion, to correspond to the shape ofa body lumen through which the overtube 24 is being inserted. This canbe achieved by forming the overtube 24 from different materials, varyingthe diameter or thickness of the overtube 24, and/or using various othersuitable techniques known to those of ordinary skill in the art. Aperson skilled in the art will appreciate that the overtube 24 can havevirtually any configuration that allows the overtube 24 to flex as it isinserted through a tortuous body lumen. The overtube 24 can also includeother features to facilitate use, such as one or more spiral wiresembedded therein in a configuration to prevent kinking of the overtube24 during flexure, for example. In various embodiments, the protectivesleeve 18, the inflation conduit 12, and/or the conduit 11 may includeany suitable features discussed above with respect to the overtube 24,for example.

The surgical device 10 as described herein can have many uses. Anon-limiting example of one particular use is described below withreference to FIGS. 17 and 18. In various embodiments, a flexibleendoscopic portion 131 of an endoscope 160 (e.g., gastroscope) isinserted into an upper gastrointestinal tract of a patient. FIG. 17illustrates the surgical device 10 inserted through a natural orificesuch as the mouth 110 and esophagus 112 into the stomach 114 toestablish an opening in the stomach 114 for performing a surgicaloperation such as a gall bladder removal or a cholecystectomy, forexample. FIG. 18 illustrates a distal portion 132 of the endoscope 160.As shown in FIGS. 17 and 18, the endoscope 160 may comprise the distalportion 132 and a proximal portion 140. In at least one embodiment, anovertube 130, configured to receive at least the endoscopic portion 131of the endoscope 160, can be inserted into the mouth 110 and can extendtowards and/or into the stomach 114. The overtube 130 can create aworking channel for insertion of the endoscopic portion 131 of theendoscope 160. In various embodiments, the overtube 130 may befabricated from nylon or high-density polyethylene plastic, for example.In various embodiments, the endoscopic portion 131 can define variousworking channels 138 that extend at least from the natural orifice 110to the surgical site. In addition, the endoscopic portion 131 may definea viewing port 136, for example. As such, the endoscope 160 may be usedfor viewing the surgical site within the patient's body. Various camerasand/or lighting apparatuses may be inserted into the viewing port 136 ofthe endoscope 160 to provide the surgeon with a view of the surgicalsite.

In the embodiment illustrated in FIG. 17, one of the tools, devices, orsurgical instruments that can be accommodated in the working channels138 is a hollow vacuum/air tube 150 that may be in fluid communicationwith a fluid source such as at least one of a vacuum source 152 and apressurized air source 154. In one embodiment, the vacuum/air tube 150can be sized to receive therein another surgical instrument in the formof the endoscope 160. A variety of different types of endoscopes areknown and, therefore, their specific construction and operation will notbe discussed in great detail herein. In various embodiments, theendoscope 160 may operably support a video camera that communicates witha video display unit 164 that can be viewed by the surgeon during thesurgical procedure. In addition, the endoscope 160 may further comprisea fluid-supply lumen therethrough that is coupled to a source of water172, saline solution, and/or any other suitable fluid and/or an airsupply lumen that is coupled to a source of air 178.

In use, the surgical device 10 can be inserted into one of the workingchannels 138 through either working channel port 141 or 143 and thenthrough either working channel tube 146 or 147 to working channel 138and used to puncture, pierce, create, or incise an opening in tissue “T”proximal to the surgical site. As illustrated in FIGS. 17 and 18, aportion of the surgical device 10 can extend from the distal end of theworking channel 138 to enable access to the tissue “T.” In variousembodiments, the surgical device 10 can function as explained herein.

In various embodiments, again referring generally to the various stagesof deployment illustrated in FIGS. 12-16, a method of using the surgicaldevice 10 is provided. First, the surgeon can insert an overtube 24 intoa natural opening of a patient, such as the mouth, for example. Thesurgeon can then either insert a portion of the endoscope 26 into theovertube 24 or can simply insert the surgical device 10 into theovertube 24. In many instances, the surgeon may insert the portion ofthe endoscope 26 before inserting the surgical device 10 to allow thesurgeon to view the surgical site via a viewing port of the endoscope26. In such an instance, the surgeon can position the surgical device 10within and at least partially through the working channel 28 of theendoscope 26. As the surgical device 10 is inserted into the workingchannel 28 or the overtube 24, the protective sleeve 18 can be in thefirst position where it at least partially covers, shields, and protectsthe inflatable member 16 to prevent, inhibit, or at least minimizetearing or puncturing the inflatable member 16 during insertion. Once adistal end of the surgical device 10 reaches the surgical site, thesurgeon can then turn on a vacuum producing device to create negativepressure conditions or subatmospheric pressure conditions within theovertube 24. These conditions within the overtube 24 can cause a portionof the tissue 32 near the surgical access site or surgical site to be atleast partially drawn into the distal end of the overtube 24 such thatthe portion of the tissue 32 can be punctured by the helical element 14of the surgical device 10.

To puncture the portion of the tissue 32, the surgeon can advance thedistal end of the helical element 14 into and insert it into the tissue32 by applying a proximal-to-distal (i.e., pushing) force, in thedirection indicated by arrow “A,” to the proximal portion of the helicalelement 14. The helical element 14 is then threaded in a clockwisedirection “CW” to pierce and penetrate the tissue 32 and create theopening 34. After the helical element 14 has created the opening 34 inthe tissue 32, the surgeon can then advance the distal end of theinflation conduit 12 into and through the opening 34 by applying aproximal-to-distal (i.e., pushing) force, in direction “B,” to theproximal portion of the inflation conduit 12. In such an embodiment, thesurgeon can also apply a proximal-to-distal (i.e., pushing) force to thehandle 20 or proximal portion of the protective sleeve 18 to ensure thatthe protective sleeve 18 remains in the first position during insertionof the distal end of the inflation conduit 12 into and at leastpartially through the opening 34 in the tissue 32. In other variousembodiments, a portion of the protective sleeve 18 can be releasablyengaged with a portion of the inflation conduit 12 or a portion of theinflation conduit 12 to prevent, inhibit, or at least minimize slidingof the protective sleeve 18 at inappropriate times during the surgicalprocedure. As discussed previously, by maintaining the protective sleeve18 in the first position during insertion into the opening 34 in thetissue 32, the inflatable member 16 can be substantially protected frompuncturing, tearing, and/or premature inflation under subatmosphericpressure conditions within the overtube 24. Next, the surgeon can moveand/or retract the protective sleeve 18 from the first position to asecond position thereby exposing the inflatable member 16 to thesidewalls 36 of the opening 34. As previously discussed, the protectivesleeve 18 can be moved using the handle 20 or by pushing or pulling theproximal portion of the protective sleeve 18, for example. Also, asdiscussed above, this movement of the protective sleeve 18 can beaccomplished through the use of other mechanical members, such asthreads, for example, or through suitable automated members, forexample.

Once the protective sleeve 18 has been retracted into the secondposition, the surgeon can then activate the fluid source 22 to beginfilling the inflatable member 16 via the inflation conduit 12 or theconduit 11. Filling the inflatable member 16 can cause the opening 34 inthe tissue 32 to be enlarged as the inflatable member 16 applies a forceto the sidewalls 36 of the opening 34 during expansion. Once the opening34 has been sufficiently expanded, the overtube 24 and the endoscope 26can be pushed or advanced through the opening 34 in the tissue 32.Subsequently, the inflatable member 16 can be deflated and the surgeoncan remove the surgical device 10 from the overtube 24 or workingchannel 28 and insert appropriate surgical instruments or devices tobegin or continue a surgical procedure.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the devices can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the devices, followed by the cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicescan be disassembled, and any number of the particular pieces or parts ofthe devices can be selectively replaced or removed in any combination.Upon the cleaning and/or replacement of particular parts, the devicescan be reassembled for subsequent use either at a reconditioningfacility or by a surgical team immediately prior to a surgicalprocedure. Those skilled in the art will appreciate that thereconditioning of the devices can utilize a variety of techniques fordisassembly, cleaning/replacement, and reassembly. The use of suchtechniques, and the resulting reconditioned devices, are all within thescope of the present application.

Preferably, the various embodiments described herein will be processedbefore surgery. First, a new or used device is obtained and, ifnecessary, cleaned. The device can then be sterilized. In onesterilization technique, the device is placed in a closed and sealedcontainer, such as a plastic or TYVEK® bag. The container and device arethen placed in a field of radiation that can penetrate the container,such as gamma radiation, x-rays, or high-energy electrons. The radiationkills bacteria on the device and in the container. The sterilized devicecan then be stored in the sterile container. The sealed container keepsthe device sterile until it is opened in the medical facility. It ispreferred that the device is sterilized. This can be done by any numberof ways known to those skilled in the art, including beta or gammaradiation, ethylene oxide, or steam.

Although the various embodiments have been described herein inconnection with certain disclosed embodiments, many modifications andvariations to those embodiments may be implemented. Also, wherematerials are disclosed for certain components, other materials may beused. The foregoing description and following claims are intended tocover all such modifications and variations.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

What is claimed is:
 1. A surgical device, comprising: a guide tubehaving a proximal end, a distal end, and an inside diameter; aprotective sleeve having an inner diameter larger than an outer diameterof the guide tube; a needle having a proximal end and a distal end, theneedle comprising: a longitudinal portion having a diameter suitable tobe slidably received within the inside diameter of the guide tube; and ahelical element comprising a tube or a wire formed into a helical shapedisposed at the distal end of the needle, wherein a distal end of thehelical element is suitable for piercing tissue, and wherein a tip ofthe distal end of the helical element is configured to pierce the tissuethrough rotation of the helical element in a direction perpendicular tothe longitudinal portion; and a tapered element located distallyrelative to the longitudinal portion and proximally relative to thehelical element, the tapered element having a diameter less than thediameter of the longitudinal portion and a diameter of the tube or thewire of the helical element, the tapered element being configured toextend beyond the distal end of the guide tube and being configured tocollapse by drawing, in a direction parallel to the longitudinalportion, the longitudinal portion closer to the helical element, when aforce parallel to the longitudinal portion of the needle is applied tothe proximal end of the needle during piercing of the tissue, thecollapse of the tapered element to prevent a build up of pressureagainst the tissue by the needle, wherein the tapered element is shorterrelative to the longitudinal portion; wherein the protective sleeve isable to be positioned at least partially over the helical element. 2.The surgical device of claim 1, wherein the tapered element comprises: afirst tapered segment; a second tapered segment; and a middle segmentlocated between the first and second tapered segments, the middlesegment having a diameter which is less than any one of the diameter ofthe longitudinal portion and the diameter of the tube or wire of thehelical element.
 3. The surgical device of claim 2, wherein the firsttapered segment reduces the diameter of the longitudinal portion of theneedle to a reduced diameter of the middle segment; and wherein thesecond tapered segment reduces the diameter of the tube or the wire ofthe helical element to the reduced diameter of the middle segment. 4.The surgical device of claim 3, wherein the diameter of the longitudinalportion of the needle is substantially the same as the diameter of thetube or the wire of the helical element.
 5. The surgical device of claim3, wherein the diameter of the longitudinal portion of the needle isdifferent from the diameter of the tube or the wire of the helicalelement.
 6. The surgical device of claim 1, wherein the helical elementis formed of a shape memory alloy.
 7. The surgical device of claim 1,wherein the helical element is integrally formed with the longitudinalportion of the needle.
 8. The surgical device of claim 1, wherein thehelical element is rotatable by rotating the distal end of the needle.9. The surgical device of claim 1, comprising a conduit to slidablyreceive the guide tube.
 10. The surgical device of claim 1, furthercomprising: a conduit having an inner diameter larger than the outerdiameter of the guide tube; an inflatable member at least partiallysurrounding a portion of the conduit and positioned proximal to thedistal end of the guide tube, the inflatable member comprising an outerperimeter; and an inflation conduit having an inner diameter and beingattached to a proximal portion of the inflatable member; and wherein theinner diameter of the protective sleeve is larger than an outer diameterof the conduit; and wherein the inner diameter of the protective sleeveis larger than an outer diameter of the inflation conduit; and whereinthe inner diameter of the inflation conduit is larger than the outerdiameter of the conduit.
 11. The surgical device of claim 10, whereinthe protective sleeve is moveable at least between a first position anda second position, the protective sleeve configured to shield theinflatable member when the sleeve is in the first position, and theprotective sleeve configured to expose the inflatable member forinflation when the sleeve is in the second position.
 12. A surgicaldevice, comprising: a guide tube having a proximal end and a distal end;a protective sleeve having an inner diameter larger than an outerdiameter of the guide tube; an inflatable member at least partiallysurrounding a portion of the guide tube and positioned proximal to thedistal end of the guide tube, the inflatable member comprising an outerperimeter; a needle having a proximal end and a distal end, wherein theproximal end of the needle is attached to the distal end of the guidetube; a helical element comprising a tube or a wire formed into ahelical shape disposed at the distal end of the needle, wherein thehelical element is configured to pierce tissue through rotation of thehelical element; and wherein the protective sleeve surrounds at least aportion of the guide tube and is able to be positioned at leastpartially over the helical element, the protective sleeve moveable atleast between a first position outside an incision of the tissue createdby piercing of the tissue by the helical element and a second positionat least partially inside the incision of the tissue, the protectivesleeve configured to: shield the inflatable member throughout theprotective sleeve moving from the first position to the second position,wherein the inflatable member is positioned at least partially insidethe incision of the tissue at the second position; and expose theinflatable member for inflation by moving from the second position tothe first position, the inflatable member remaining at the secondposition; and wherein the inflatable member is configured to inflatewhile at least partially inside the incision of the tissue at the secondposition.
 13. The surgical device of claim 12, further comprising atapered element located distal to the guide tube and proximally relativeto the helical element, the tapered element having a diameter less thanthe outer diameter of the guide tube and a diameter of the tube or wireof the helical element, wherein the tapered element is shorter relativeto the guide tube; and wherein the tapered element comprises: a firsttapered segment; a second tapered segment; and a middle segment locatedbetween the first and second tapered segments, the middle segment havinga diameter which is less than any one of the outer diameter of the guidetube and the diameter of the tube or wire of the helical element. 14.The surgical device of claim 13, wherein the first tapered segmentreduces the outer diameter of the guide tube to a reduced diameter ofthe middle segment, and wherein the second tapered segment reduces thediameter of the tube or the wire of the helical element to the reduceddiameter of the middle segment.
 15. The surgical device of claim 14,wherein the outer diameter of the guide tube is substantially the sameas the diameter of the tube or the wire of the helical element.
 16. Thesurgical device of claim 14, wherein the outer diameter of the guidetube is different from the diameter of the tube or the wire of thehelical element.
 17. The surgical device of claim 12, wherein thehelical element is formed of a shape memory alloy.
 18. A surgicaldevice, comprising: a guide tube comprising a proximal end and a distalend; a conduit having an inner diameter larger than an outer diameter ofthe guide tube; an inflatable member at least partially surrounding aportion of the conduit and positioned proximal to the distal end of theguide tube, the inflatable member comprising an outer perimeter; asleeve at least partially surrounding a portion of the guide tube, thesleeve comprising an elongate channel comprising an inner diameterlarger than the outer diameter of the guide tube and larger than anouter diameter of the conduit; and a needle configured to be slidablydisposed within the guide tube located distally relative to theinflatable member, the needle comprising: a longitudinal portionslidably disposed within an inside diameter of the guide tube; a helicalelement comprising a tube or a wire formed into a helical shape disposedat a distal end of the needle, wherein a tip of a distal end of thehelical element is suitable for piercing tissue, and wherein the helicalelement is configured to pierce the tissue through rotation of thehelical element; and a tapered element located distally relative to thelongitudinal portion and proximally relative to the helical element;wherein the tapered element comprises: a first tapered segment; a secondtapered segment; and a middle segment located between the first andsecond tapered segments, the middle segment having a diameter which isless than a diameter of any one of the longitudinal portion of theneedle and the helical element, wherein the tapered element is shorterrelative to the longitudinal portion; wherein the sleeve is moveable atleast between a first position outside an incision of the tissue createdby piercing of the tissue by the helical element and a second positionat least partially inside the incision of the tissue, the sleeveconfigured to: shield the inflatable member throughout the sleeve movingfrom the first position to the second position, wherein the inflatablemember is positioned at least partially inside the incision of thetissue at the second position; and expose the inflatable member forinflation by moving from the second position to the first position, theinflatable member remaining at the second position; and wherein theinflatable member is configured to inflate while at least partiallyinside the incision of the tissue at the second position.
 19. Thesurgical device of claim 18, wherein the sleeve is further configured tocover the inflatable member when the sleeve is in the first position toat least inhibit the inflatable member from inflating undersubatmospheric pressure conditions.